Medical & Scientific Writing & Publication Services
Kathy is an independent consultant with an extensive background in the area of Clinical Trial Disclosure. She has followed the development and consolidation of the law in the US (FDAAA 2007, ClinicalTrials.gov platform) and is currently observing the developments on this topic in the European Union and European Economic Area (EU Clinical Trial Regulation 2014, EudraCT platform). She has broad knowledge and experience in preparing entries for the registries, and developing internal guidelines and processes to assure compliance with clinical trial disclosure policies; is an active member of professional international work groups on this topic.
Kathy is also a medical writer, with more than 18 years of experience in the academic and pharmaceutical industry setting, preparing a wide range of clinical and drug safety documents for modules of the Common Technical Document for regulatory submissions, investigator’s brochures, aggregate drug safety documents (PSUR, DSUR), manuscripts for peer-review journals, abstracts, posters, and slide presentations for international scientific and medical conferences. Kathy has served as the Head of Medical Writing from 2001-2007 at Altana Pharma AG, Konstanz, Germany. She resides in southern Germany and speaks English, German, Czech, and Slovak fluently.